Big Endo Groups Plan Meeting on D-Device Accuracy & Access

Email addresses will not be shared with 3rd parties. See privacy policy

Thank you.

Your message has been sent.

OK

We're sorry, an error occurred.We are unable to collect your feedback at this time. However, your feedback is important to us. Please try again later.

Close

There's been a lot of talk in the diabetes patient community lately about the accuracy of existing glucometers and issues of access to these and other, more advanced diabetes devices like insulin pumps and continuous glucose monitors (CGMs). Now, two of the nation's biggest endocrinologist groups are entering the conversation in a way that no other group of diabetes physicians has done before!

While this is great news, there seems to be some contention in the ranks of the various groups working to "address issues tied to quality, safety and access to glucose monitoring devices and related supplies that patients use to ensure that their disease is under control" (in the AACE's words).

That legislation, known as the National Diabetes Clinical Care Commission Act (H.R. 1074/S. 539), would create a 3-year "Diabetes Clinical Care Commission" made up of endos, diabetes specialists, patient advocates and federal agency officials to examine the U.S. investments and improve clinical outcomes for diabetes and pre-diabetes.

Other orgs like ADA, AADE, JDRF, the Endocrine Society, and so on have endorsed the legislation, which needs to be passed during this session with a vote before December 31.

Per the news release: "The blood glucose monitoring initiative will be uniquely structured to gather input from all major stakeholders involved in the diabetes arena and will examine critical factors such as regulatory challenges, post-FDA-approval monitoring of safety and accuracy of glucose strips, glucose sensors and devices, patient access and economic/reimbursement issues."

Michigan endocrinologist Dr. George Grunberger, chair of the task force for this conference and president-elect of AACE, says they intend to be collaborative, and are inviting "a range of stakeholders" including the Diabetes Technology Society (DTS) that's already making headway on a post-market surveillance program announced in May, and "heavy representation" from patient advocates, i.e. the StripSafely initiative leaders (the invite list is still being developed and not public yet).

But in the same breath, Grunberger wasn't shy about noting that "other efforts" on the points of diabetes accuracy and access aren't good enough. This conference "goes way beyond any of the past individual efforts," he says.

"Past or ongoing initiatives (in which AACE has participated) dealing with competitive bidding at Medicare, CGM coverage by CMS, any planned post-marketing strip quality surveillance studies, etc. are all important and ongoing. They are just part of the overall picture (and will be covered at the consensus conference). Clearly, none of these efforts have yielded anything substantial for our patients and are highly unlikely to result in anything different in the future other than more talking. There will always be individuals at FDA, CMS and other agencies who will hide behind real or perceived legal constraints of their agencies. Something different and bigger is necessary."

Whoa! A little harsh about other efforts happening out there, no?

It's true that as Grunberger says, nothing like this conference has been done before. But if you think about it, that's rather surprising. Why haven't the large national organizations of diabetes physicians gathered or spoken out on the issues of access and accuracy before, given that they're such longstanding and key challenges to patient success? (rhetorical question)

And why is this effort so different?

"The overarching goal of this new gathering is a consensus of all relevant parties about the issues and potential solutions, but mainly to demonstrate to Congress that there is a way of getting action if you allow an objective airing of data-driven views by all stakeholders," he said. "This is how the Diabetes Clinical Care Commission would work. The immediate offshoot will be Congressional briefings and visitations the day after the conference, acquainting Members with the highlights of the consensus and pushing to get more co-sponsors for the bill."

We're actually pretty excited about the new DTS Surveillance Program for Cleared Blood Glucose Monitors, an effort led by Dr. David Klonoff from the University of California San Francisco (UCSF) that's been discussed for years but finally coming to fruition within the past year. This program aims to do the work that FDA practically and by law cannot -- literally buy existing glucose meters and strips off store shelves, test them for accuracy, and then publish the results for the public and regulators to see. Abbott Diabetes Care is currently funding this, and DTS is already creating the groups that would head up activities planned to begin in 2015.

We are very enthusiastic, especially knowing that as part of this effort, FDA is communicating with CMS behind-the-scenes about the bigger accuracy and coverage picture. And if this program has any legs, it could influence decision-makers to start looking at this data in determining which meters and strips to cover and offer through their much-debated competitive-bidding program.

But Grunberger isn't so optimistic.

"Just a word of caution about the DTS efforts: even if it happens, any results won't be available for at least a year and there is no guarantee that FDA will pay them any more attention than it has to date to the independent strip quality studies," he tells us. "If you read the DTS press release, it does not state specifically that FDA supports that particular program since studies have not been formulated yet ... (but) if any data are available by end of September, DTS has already been invited to present them at the conference."

So, we can't wait to see what appears on the agenda for this September gathering.

While the leaders of these efforts may quibble, from the patient's perspective, we should at least be encouraged to see public discussions about these issues and some sort of effort to work together to make positive changes -- right?

And hopefully, with the powerhouse doctor-groups AACE and ACE hitting Capitol Hill, some more of our elected-leaders will get behind the pending legislation to make diabetes care a bigger priority.

Disclaimer: Content created by the Diabetes Mine team. For more
details click
here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community.
The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines.
For more information about Healthline's partnership with Diabetes Mine, please click here.

Hey Diabetes Community! Back-to-School time is right around the corner once again, but don't worry -- the College Diabetes Network has your back!Not quite a decade old, this Boston-based organization has been growing by leaps and bounds, and very ...

One of the most magical times in diabetes happens every year in July, with the annual Friends For Life conference put on by the non-profit Children With Diabetes organization.Don't let the name fool you -- it's not just for kids. Adults with diabe...

Big news broke last week that could change the future of closed loop technology.OK, it's tempting to refer to this as "Bigfoot" news... as in Bigfoot Biomedical, the closed loop (aka Artificial Pancreas system) startup based in Milpitas, CA, led...

Ever since she was a little girl (with type 1 diabetes), Elizabeth Forrest has had a love for dancing. And at just 11 years old, she had an idea to combine that love with awareness and fundraising for diabetes. Now a twenty-something in Central Fl...

You asked, albeit rhetorically, why organizations haven't spoken out on access. Unfortunately, sometimes they have, using information from badly controlled short-term research studies, and have stated that self-monitoring is costly and unnecessary. If a doctor hands a patient a meter and doesn't help them understand how to use the number that appears and doesn't give the patient any means to lower a high blood sugar, giving them a prescription for a few test strips is not going to result in a lower A1c or reduced complications. Further better studies have proven the opposite: frequent testing along with assistance using those numbers to alter behaviors prolongs life. Many doctors, insurance companies and members of Congress base their decisions on those original, badly done studies.

Joan McGinnis|2014-06-13

It would seem that including AADE representatives would be a very good idea, since certified diabetes educators are the ones who do instruction and know the most about these devices.

Advertisement

Advertisement

Advertisement

Advertisement

Advertisement

Advertisement

Advertisement

Close

Advertisement

As the fastest growing consumer health information site — with 65 million monthly visitors — Healthline’s mission is to be your most trusted ally in your pursuit of health and well-being.

You can depend on us to provide expert content along with genuine caring. Both of which will support, guide, and inspire you toward the best possible health outcomes for you and your family.